Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal … [Read more...] about Medtronic launches DCB for dialysis patients in Japan
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The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. The agency 2020 tagged a total of 33 medical device recalls as Class I — the most serious level — down from 49 in 2019. The list of the most serious catheter-based device recalls in 2020 includes products from … [Read more...] about The worst catheter-based device recalls of 2020
Medtronic touts recently acquired Rist catheters for neurovascular procedures
Medtronic today announced an early, site-limited release of its recently acquired Rist radial access guide catheters. The Rist 079 catheter is designed for the introduction of interventional devices into the peripheral, coronary and neuro vasculature using the radial artery in the wrist. The Rist radial access selective catheter is designed to … [Read more...] about Medtronic touts recently acquired Rist catheters for neurovascular procedures
Medtronic has a Class I recall involving balloon catheters to treat heart defects
FDA today designated a Medtronic recall of Rashkind balloon septostomy catheters as Class I, its most serious level. The balloon catheters create an atrial septal defect or to enlarge an existing atrial septal defect in order to treat congenital heart defects. Medtronic (NYSE:MDT) initiated a recall of the Rashkind balloon septostomy … [Read more...] about Medtronic has a Class I recall involving balloon catheters to treat heart defects
FDA approves Medtronic venous stent
Medtronic this week announced that it received FDA approval for its Abre venous self-expanding stent system. The device is indicated for use in the iliofemoral veins in patients that have symptomatic iliofemoral venous outflow obstruction. "Patients with deep venous obstruction are often younger, therefore it's critical to have a venous stent … [Read more...] about FDA approves Medtronic venous stent
Medtronic Resolute Onyx stent gains expanded FDA clearance
Medtronic today said it received FDA clearance for an expanded indication of its Resolute Onyx drug-eluting stent (DES). The new indication allows for one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk patients that are implanted with the device. Resolute Onyx is the only DES in the U.S. … [Read more...] about Medtronic Resolute Onyx stent gains expanded FDA clearance
Medtronic touts cryoablation therapy study results
Medtronic (NYSE:MDT) touted results demonstrating the superiority of two of its cryoablation therapy technologies. Fridley, Minn.-based Medtronic said in a news release that trials showed the superiority of the Arctic Front advance cardiac cryoballoon and the Freezor max cardiac cryoablation catheter for the first-line treatment (before drug … [Read more...] about Medtronic touts cryoablation therapy study results
Study: Medtronic’s drug-coated balloon reduces dialysis interruptions
Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment. Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. … [Read more...] about Study: Medtronic’s drug-coated balloon reduces dialysis interruptions
Medtronic recalls certain balloon catheters
Medtronic is voluntarily recalling certain balloon dilation catheters that have proven difficult to remove from patients’ bodies. The recall affects a subset of the company’s Euphora and Solarice semi-compliant rapid exchange balloon dilatation catheters manufactured from February 27, 2019, through July 31, 2019, according to a letter sent to … [Read more...] about Medtronic recalls certain balloon catheters
Innovative Health lands another catheter reprocessing clearance
Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse. The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr … [Read more...] about Innovative Health lands another catheter reprocessing clearance
